Status:
COMPLETED
Screening of Sleep Apnea by Holter Electrocardiography: Validation of Heart Rate Variability Analysis Algorithm
Lead Sponsor:
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
Collaborating Sponsors:
Amatis Software and Fysiologic Smart ECG Solutions
Conditions:
Sleep Apnea Syndromes
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Obstructive sleep apnea syndrome (OSAS) is a growing health concern affecting up to 60 % of population with cardiovascular disease. Despite the high cardiovascular morbidity and mortality associated w...
Detailed Description
To find out whether a new algorithm of HRV analysis from holter ECG monitoring can be used as a screening test for the diagnosis of patients with moderate-to-severe risk of obstructive sleep apnea syn...
Eligibility Criteria
Inclusion
- The patients will be recruited from individuals referred to our university hospital's sleep center for a polysomnography recording because of clinically suspected OSAS (with at least one of the following obstructive sleep apnea symptoms: witnessed apnea, snoring and/or daytime sleepiness)
Exclusion
- Permanent or paroxysmal atrial fibrillation, permanent pacemaker, severe cardiopulmonary disease, severe diabetes mellitus, autonomic dysfunction or major physical or mental ailments.
Key Trial Info
Start Date :
May 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2022
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT05435001
Start Date
May 5 2022
End Date
August 1 2022
Last Update
February 21 2023
Active Locations (1)
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1
Izmir Dr Suat Seren Chest Disease and Surgery Training and Research Hospital
Izmir, Turkey (Türkiye), 35110